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Sat April 6, 2013

With Plan B Ruling, Judge Signs Off On Years Of Advocacy

A federal judge has ordered the Food and Drug Administration to make all levonorgestrel-based emergency contraceptives available to younger teens without a prescription.

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A federal judge ordered Friday what women's groups have failed to accomplish politically for a dozen years. He ruled that Plan B, the most commonly used morning-after birth control pill, be sold without a prescription or other restrictions to women of all ages.

Federal District Court Judge Edward Korman has been overseeing the case on and off since 2005. He found, among other things, that the Food and Drug Administration "has engaged in intolerable delays ... that could accurately be described as an administrative agency filibuster" in deciding whether to approve a 2001 citizens' petition to allow nonprescription sale of the drug.

"Her decision was arbitrary, capricious, and unreasonable," the judge wrote.

Korman ordered the FDA to grant the petition (originally filed by the Center for Reproductive Rights) within 30 days to make all levonorgestrel-based emergency contraceptive products available "without a prescription and without point-of-sale or age restrictions." Those products include Plan B, in both one- and two-pill configurations, and Next Choice, a generic version.

The White House's Response

It remains unclear whether the administration will appeal the ruling. At the White House on Friday, spokesman Jay Carney said that from a policy point of view, nothing has changed.

"Secretary Sebelius made this decision," he said. "The president supported that decision after she made it, and I think said so in the briefing room when he was asked about it. And he supports that decision today."

Carney, however, along with spokespeople at HHS and FDA, referred legal inquiries to the Justice Department. The Justice Department issued a statement saying it is "reviewing the appellate options and expects to act promptly."

'A Big Victory'

Advocates for the drug, meanwhile, were thrilled with the ruling.

"Today, science has finally prevailed over politics because a judge has ruled that it must," Nancy Northup, president and CEO of the Center for Reproductive Rights, said. "This is enormous. This is going to be a big victory for women."

Lifting age restrictions isn't just beneficial for younger teens, advocates say. They argue the status quo also created barriers for older women. Those who didn't need a prescription still had to request Plan B from behind the pharmacy counter.

"And so all women are having to find open pharmacies and come with their government ID, and go through a series of lines or questions or asking for the product," said Susan Wood, who quit her post at the FDA over its refusal to make Plan B available without a prescription in 2005.

"[It's] unlike anything you would ever see for any other over-the-counter birth control methods or any other over-the-counter medicines," she said.

'Particularly Controversial'

Wood, now a health policy professor at George Washington University, said she was also pleased the judge noted that Plan B does not cause even the earliest of abortions.

"This is a product that's clearly a contraception product and that can help all women prevent unintended pregnancy, and therefore it should be common ground and not politicized," she said.

Indeed, Judge Korman managed to single out in a few sentences exactly what has made the issue just so politically potent for so many years:

"This case has proven to be particularly controversial because it involves access to emergency contraception for adolescents who should not be engaging in conduct that necessitates the use of such drugs and because of the scientifically unsupported speculation that the drug could interfere with implantation of fertilized eggs."

Still In Opposition

But opponents remain unhappy, both with the drug and with the idea that it could be freely available to young girls.

"In obtaining these drugs over the counter, these girls are going to be bypassing important medical screenings, which could screen for [sexually transmitted diseases] and also are the first-line defense in screening for girls at risk of sexual abuse," said Anna Higgins, director of the Center for Human Dignity at the Family Research Council.

"Teen girls need parents, not unfettered access to abortion-inducing drugs," said Marjorie Dannenfelser, president of the Susan B. Anthony List.

Another question is whether making the drug available without prescription might actually make it less accessible to some. Over-the-counter drugs generally are not reimbursed by insurance and a dose of Plan B One Step generally costs $40 to $50.

"We're going to continue to work with our fellow advocates to make sure that it is affordable for women," said Northup of the Center for Reproductive Rights.

But making the morning-after pill fully nonprescription does remove one line of argument from those who are suing over the Affordable Care Act's contraceptive coverage requirement. Nonprescription products are not included in that provision.

Copyright 2014 NPR. To see more, visit http://www.npr.org/.

Transcript

RACHEL MARTIN, HOST:

A recent ruling by a federal judge in New York may have ended a 13-year-long fight over one aspect of women's health - or maybe not. The judge ordered the Food and Drug Administration to drop all restrictions on the sale of the most widely used morning-after pill. According to the ruling, the pills would be available to anyone of any age on drugstore shelves. NPR's Julie Rovner has been covering the debate over Plan B since 2001. She joins us in the studio now to explain the latest. Hi, Julie.

JULIE ROVNER, BYLINE: Hey, Rachel.

MARTIN: So, tell us what the judge ordered specifically and what does it mean for women who use this product?

ROVNER: Well, U.S. District Judge Edward Korman, who's actually had this suit before him in one form or another for more than eight years, has technically ordered the Food and Drug Administration to approve a citizens' petition asking that the morning-after pill be made available to all women without a prescription regardless of age within 30 days.

MARTIN: OK. And how is that different from what happens in a drugstore now?

ROVNER: Well, now the drug is available without a prescription to those 17 and older, but if you're 16 and younger you do need a doctor's order. Notice I didn't say it's available over-the-counter to those 17 and older. That's because it's kept what's known as behind the counter, which means that women need to ask for it. Usually, they have to show ID. And there have been a lot of cases reported where even adults have had a hard time getting it. In some cases, pharmacists have incorrectly thought they can't sell it to boyfriends or husbands. So, the groups who've been pushing to eliminate the age restrictions haven't been just arguing that they want to make the product more available to younger teens but more available to older women as well. That's important because while it works up to 72 hours after unprotected sex, the sooner you take it, the more effective it is.

MARTIN: Julie, this fight over Plan B has been going on for a long time, as we said, since 2001. What makes this particular drug so controversial?

ROVNER: Well, the judge actually talked about that in his decision, and I think it's really two things. First of all, it involves access to emergency contraception for adolescents, who, as the judge said, shouldn't be engaging in conduct that necessitates the use of those drugs. But also because, as he said, there's a scientifically unsupported speculation that the drug could interfere with implantation of fertilized eggs. In other words, cause a very early abortion. That's really important 'cause there's been a continuing fight over whether these pills can stop a fertilized egg from implanting in a woman's uterus. Some people believe that constitutes an abortion. Recent studies, which have actually come out during the course of this fight, seem to show pretty conclusively that's not the case, that Plan B really only prevents the egg from being released, so it really only is a contraceptive.

MARTIN: So, what happens now? I assume there are still people who would like to see this pill stay restricted for younger girls.

ROVNER: Absolutely. There are a lot of groups that worry about its potential effect on younger teens' health. They worry about the possibility of sexual predators forcing it on young girls. They worry that, like all birth control pills, it doesn't protect against sexually transmitted diseases. And those were some of the concerns expressed by Health and Human Services Secretary Kathleen Sebelius in 2011 when she overruled the FDA, which at that point was ready to lift the age restrictions. And by the way, that's what FDA scientists and experts had recommended, that they be lifted. But now the administration basically has to decide whether it wants to appeal the ruling, which would anger women's health groups, or leave it alone and anger conservative groups who are worried about the impact on young girls.

MARTIN: Which is a big decision. Have you gotten any indications as to what the administration is likely to do?

ROVNER: Not really. On Friday, White House spokesman Jay Carney said despite the judge's very harsh words for Secretary Sebelius' actions, which the judge called obviously political, the administration continues to support the policy of maintaining the restrictions. But Jay Carney also said the final decision's up to the Justice Department. So, I wouldn't be surprised to see the Justice Department quietly decide just to let this judge's ruling take effect.